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Regulatory Research Coordinator

Location : Buffalo, NY
Job Type : Temp/Contract
Start Date : 03/22/2021
Hours : Full Time
Travel : No
Relocation : No

Job Description :

The Regulatory Research Coordinator supports the clinical research mission of the Institute and Clinical Research Services (CRS) through the creation, submission and maintenance of research regulatory documents. The employee adheres to the Code of Federal Regulations (Title 21) and guidelines set up by the GCP/ICH and the FDA.

Required Qualifications :

Required Education and Experience:

1. Bachelor's degree and the equivalent of one (1) year full-time experience in clinical research or health related field: or
2. Associate's degree and the equivalent of two (2) years of full-time experience in clinical research or a health related field.



The preferred candidate will have a Bachelor's Degree; Current applicable Regulatory Research Experience in Clinical Research Services; Experience with CDT meeting interactions, report preparation and tracking; Experience entering and working in the CRS OnCore platform (CTMS); current experience preparing submissions in CLICK IRB System; Current applicable knowledge of Regulatory level Clinical Research Services SOP and Work Instructions; Subject Protection CITI course completion; Proficiency with MS Office application skills especially MS Word and MS Outlook and experience with pharmaceutical sponsor monitor visit interactions.

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